ESRC3D: Super-Resolution Ultrasound of the Brain in 3D

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06133179

Collaborator

Centre National de la Recherche Scientifique, France (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The goal of this proof of concept study is to determine if the visualization of the middle cerebral artery and its perforators, through 3D transtemporal ultrasound imaging, is possible thanks to an off-line analysis by 3D ultrasound localization microscopy. Visualization of these vessels would allow us to conclude on the presence, or absence, of an ischemic stroke in the region of the middle cerebral artery.

To answer the question asked, 20 participants who suffered a stroke will carry out a transtemporal ultrasound examination specifically for research in the 7 days following his stroke. The data obtained will be analyzed by the CNRS medical imaging laboratory, in order to characterize the presence of a stroke and to compare the data obtained with that of standard examinations (CT and MRI).

Condition or Disease	Intervention/Treatment	Phase
Cerebral Stroke	Procedure: Transtemporal ultrasound with contrast product (Sonovue)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Proof of concept, exploratory, single group, non-comparative, uncontrolled studyProof of concept, exploratory, single group, non-comparative, uncontrolled study

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pilot Study of the Characterization of Subacute Ischemic Cerebrovascular Accidents in the Region of the Middle Cerebral Artery by 3D Ultrasound Localization Microscopy (ULM) With a Research Ultrasound System and Non-marketed 2D Matrix Probe.

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort group Routine care + transtemporal ultrasound examination with contract product during hospitalization	Procedure: Transtemporal ultrasound with contrast product (Sonovue) During their hospitalization and in the 7 days following their stroke, all patients will perform a transtemporal ultrasound including the use of Sonovue contrast product. The examination will last 1 hour and will be carried out on the opposite side of the stroke then on the side of the stroke

Arm

Intervention/Treatment

Experimental: Cohort group

Routine care + transtemporal ultrasound examination with contract product during hospitalization

Procedure: Transtemporal ultrasound with contrast product (Sonovue)

During their hospitalization and in the 7 days following their stroke, all patients will perform a transtemporal ultrasound including the use of Sonovue contrast product. The examination will last 1 hour and will be carried out on the opposite side of the stroke then on the side of the stroke

Outcome Measures

Primary Outcome Measures

Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Day 1]
Measure of the caliber of visible vessels (mm)
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Day 1]
Measure of the number of visible vessels (number)
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Day 1]
Measure of the speed of the flows (mm/sec)
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Day 1]
Measure of the directionality of the flows
Describe the vascular mapping obtained by 3D transcranial ULM of patients with ischemic stroke in the territory of the middle cerebral artery and its perforators [Day 1]
Measure of the diffusion index

Secondary Outcome Measures

Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Day 1]
vessels caliber (mm)
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Day 1]
visible vessels (number)
Compare 3D ULM with standard stroke imaging methods (TOF MRI and DWI) [Day 1]
stroke size (mm3)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient aged 18 and over
Hospitalized patient with ischemic stroke in the deep territory of the middle cerebral artery
Patient with lesion observable on MRI
Patient included between 24 hours and 7 days after the ischemic stroke
Patient with a temporal window which allows soundproofing of the polygon of Willis and the middle cerebral artery
Patient having signed free, informed and written consent
Patient affiliated to a social security system (excluding AME)

Exclusion Criteria:

Contralateral middle cerebral artery territory stroke or contralateral middle cerebral artery occlusion
Patient with contraindication to Doppler ultrasound with contrast (right-left shunt, severe pulmonary arterial hypertension)
Patient with hypersensitivity to the active princip of Sonovue (sulfur hexafluoride) or these excipients
Patient with uncontrolled systemic hypertension
Patient with respiratory distress syndrome
Patient under guardianship or curatorship
Pregnant or breastfeeding patient (positive blood pregnancy test during hospitalization)
Patient with damaged skin at the temporal level
Patient having presented in the 7 days preceding inclusion an acute coronary syndrome or suffering from unstable ischemic heart disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris
Centre National de la Recherche Scientifique, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT06133179

Other Study ID Numbers:

APHP230511

First Posted:

Nov 15, 2023

Last Update Posted:

Nov 15, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Nov 15, 2023